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CAFFEINE CITRATE 10MG/ML SOLUTION FOR INJECTION

Active substance(s): CAFFEINE ANHYDROUS

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TECHNICAL PRESCRIBING INFORMATION

Caffeine Citrate 10mg/ml Solution for Injection
Equivalent to Caffeine 5mg/ml
Prescribing Information Consult Summary of Product Characteristics before Prescribing
The following information is for healthcare professionals only
1. Composition
Each 1ml contains 10mg of caffeine citrate, equivalent to 5mg of caffeine.
Each 2ml contains 20mg of caffeine citrate, equivalent to 10mg of caffeine.
It also contains Water for Injections, Sodium Hydroxide, Dilute Hydrochloric Acid, Sodium Chloride and Citric Acid
2. Clinical Particulars
2.1 Therapeutic Indications
Treatment of apnoea of prematurity.
2.2 Posology and Method of Administration
The recommended doses of Caffeine Citrate 10mg/ml Solution for Injection are expressed below. Please note:
(a) the dose expressed as caffeine citrate is twice the dose expressed as caffeine base.
(b) given orally or intravenously, caffeine is clinically effective within 4 hours. If the patient fails to respond within this time,
a second loading dose may be given. If there is no clinical response to the second loading dose, caffeine blood levels
should be measured (see ‘special warnings and precautions for use’ Section 2.3 below).
(c) Caffeine Citrate 10mg/ml Solution for Injection is also effective when administered orally, and this route may be used
alternatively without adjusting the dose.
(d) because of the slow elimination of caffeine in this patient population, there is no requirement for dose tapering on
cessation of treatment.
(e) infants must be of sufficient respiratory maturity not to require positive pressure ventilation.
Dose of
Caffeine Citrate
10mg/ml Solution
for Injection

Dose Expressed
as
Caffeine Citrate

Dose Expressed
as
Caffeine Base

Route

Frequency

Loading Dose
See (b) above

2ml/kg

20mg/kg

10mg/kg

Intravenous
Infusion
(over 30 min) or by
oral administration

Once

Maintenance
Dose

0.5-1ml/kg*

5-10mg/kg*

2.5-5.0mg/kg*

Intravenous
Infusion
(over 10 min) or by
oral administration

Every 24
hours**

* In some cases maintenance doses higher than 10mg/kg/day (expressed as caffeine citrate) may be required to achieve maximal efficacy
(eg in continuing apnoeic episodes where plasma levels indicate the dose may be safely increased)
** Beginning 24 hours after the loading dose(s)

Treatment should be continued until the child has reached a gestational age of 37 weeks, by which time apnoea of
prematurity usually resolves spontaneously. This limit may however be revised according to clinical judgement in individual
cases, depending on response to treatment, the continuing presence of apnoeic episodes despite treatment, or other
clinical considerations.
Caffeine Citrate 10mg/ml Solution for Injection should not be given intramuscularly; being acidic, i.m. injection is likely to
be painful. When given intravenously, it should be given as a slow infusion rather than a bolus injection; there is evidence
that bolus administration may cause sudden changes in blood pressure.
Please see Section 2.3 below regarding use of filter straws.
Hepatic and Renal Impairment:
In the presence of renal impairment, a reduced daily maintenance dose of caffeine is required and the dose should be
guided by blood caffeine measurements. There is increased potential for accumulation.

2.3 Special Warnings and Precautions for Use
Care should be taken to exclude other causes of apnoea before initiation of treatment.
It is advisable to monitor plasma levels of caffeine periodically. However, at the recommended doses, frequent (more than
weekly) monitoring of plasma levels is not normally necessary unless there are concerns regarding lack of efficacy or
possible toxicity. In premature neonates, caffeine has a prolonged half-life. If higher maintenance dosages are used, the
clinician should recognise this potential for accumulation and monitor plasma caffeine levels (see SmPC for a full list of
Pharmacological Properties).
If there is inadequate clinical response to the first loading dose, a second dose may be given, but if there is continued
inadequate response, the plasma levels should be confirmed before further doses are given, as the failure to respond could
be an indication of another cause of apnoea. Plasma levels should not normally exceed 50 micrograms/ml (optimally 10-30
micrograms/ml).
There may be pre-existing caffeine in the blood of neonates
(a) whose mothers may have ingested large quantities of caffeine prior to delivery.
(b) who have previously been treated with theophylline, which is metabolised to caffeine.
There is evidence that caffeine causes tachyarrhythmias in susceptible individuals. In newborn babies this is usually a
simple sinus tachycardia. If there have been any unusual rhythm disturbances on a CTG trace before the baby is born,
caffeine should be administered with caution. Caffeine should be used with caution in infants suffering gastro-oesophageal
reflux, as the drug may exacerbate this condition.
Caffeine may increase cardiac output and heart rate in therapeutic doses. Caffeine should be used with caution in infants
with cardiac disease.
Caffeine causes a generalised increase in metabolism, which may result in higher energy and nutrition requirements during
therapy. The diuresis and electrolyte loss induced by caffeine may necessitate correction of fluid and electrolyte
disturbances.
This medicinal product contains 3.04mg sodium per 1ml of the solution. To be taken into consideration by patients on a
controlled sodium diet.
Opening the ampoules may introduce glass particles into this solution. It is recommended that the solution be filtered prior
to use by means of a suitable filter device.
2.4 Overdose
Caffeine overdose has been reported in a few cases in newborns and premature infants. There should normally be no
concern with blood levels below 50 micrograms/ml; based on limited data, toxicity seems to occur when levels over 100
micrograms/ml are reached. Symptoms of overdosage from these reports include jitteriness, tachycardia, tachypnoea,
tremor, opisthotonos, rigidity and tonic-clonic movements. In one case of overdose the patient developed compromised
circulation, vomiting and seizures. Other reported effects of gross overdose include fever, agitation, hyperexcitability,
hypertonia, gastric residues, distended abdomen, metabolic acidosis, hyperglycaemia and elevated urea levels.
Treatment of overdosage should include monitoring of blood levels of caffeine and supportive measures. Previous cases
reported resolved satisfactorily.
In severe cases of overdose, exchange transfusion should be considered. In one case, this was found to reduce plasma
caffeine levels by 40mg/L per transfusion.
3. Pharmaceutical Particulars
3.1 Incompatibilities
This medical product must not be mixed with other medicinal products except those mentioned in Section 3.2.
3.2 Special Precautions for disposal and other handling
Only clear solution without particulate matter should be used. For single use only. Any unused solution should be
discarded.
There was no detectable degradation of the solution when diluted 50/50 with commercial glucose 5%, glucose 4% saline
0.18%, and sodium chloride 0.9% infusions, when stored in disposable plastic syringes at room temperature for 4 hours.
Marketing Authorisation Number: 20346/0002 Marketing Authorisation Holder: Viridian Pharma Ltd, Newport
NP18 2AB
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Viridian Pharma on 01633 400335

3. How Caffeine Citrate 10mg/ml Solution for Injection is given
The doctor or nurse will administer Caffeine Citrate 10mg/ml Solution for Injection into a
venous infusion (drip). It can also be equally effective when given by mouth, and all or some
of the doses may be given this way when possible. This medicine should not be given by
intramuscular injection.
Opening the ampoules may introduce glass particles into this solution. It is recommended
that Caffeine Citrate 10mg/ml Solution for Injection be filtered before administration.
Filters should not then be used to administer the dose from the syringe.

The exact dose, to be determined by the doctor, depends on each baby’s needs and
response to the treatment, but will usually be:
• A starting dose of 20mg/kg of the baby’s bodyweight calculated as caffeine citrate
(equivalent to caffeine 10mg/kg or 2ml/kg of this solution). If given by injection this dose
should be infused over 30 minutes
• Followed after 24 hours by a lower daily maintenance dose of 5 to 10mg/kg of the baby’s
bodyweight calculated as caffeine citrate (equivalent to caffeine 2.5 to 5mg/kg or 0.5 to
1ml/kg of this solution). If given by injection this dose should be infused over 10 minutes.
If your baby fails to respond to the starting dose (after at least 4 hours), the doctor or nurse
may give one more additional starter dose, before continuing to the lower maintenance doses.
If your baby is given too much
Accidental overdosage: If too much caffeine solution is accidentally given to your baby, the
side effects described below may become more noticeable. In cases of very high overdosage,
fits can also occur. If signs of overdosage are noticed, please tell the baby’s doctor
immediately.
4. Possible side effects
Caffeine acts as a stimulant to the nervous system. Side effects from this action may include
restlessness or jitteriness. Caffeine may also aggravate any tendency to vomiting.
If you think your baby is showing any of these side effects, or you notice any other effects
after caffeine treatment, please tell the doctor immediately.
Other side effects are not visible, but will be detected by the monitoring equipment used in
the special care baby unit:
• your baby may produce more urine than usual, and as a consequence blood levels of
certain chemicals (sodium, calcium and glucose) may be affected.
• Increased blood pressure or heart rate.
The doctor may decide to check the levels of caffeine in a blood sample as a precaution, or
if your baby is not responding to treatment as expected.
Reporting of side effects
If you notice any side effects, talk to your doctor. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.
5. How Caffeine Citrate 10mg/ml Solution for Injection is stored
Caffeine Citrate 10mg/ml Solution for Injection needs to be kept out of the reach and sight of
children. There are no other special conditions of storage.
Use by date: Do not use Caffeine Citrate 10mg/ml Solution for Injection after the expiry date
on the label, or if there are any signs of discolouration or clouding of the solution.
6. Contents of the pack and other information
What Caffeine Citrate 10mg/ml Solution for Injection contains
The active ingredient is Caffeine Citrate 10mg/ml, equivalent Caffeine 5mg/ml.
Other ingredients are:
• water for injections
• citric acid
• sodium chloride
• sodium hydroxide
• dilute hydrochloric acid
Caffeine Citrate 10mg/ml Solution for Injection contains 3.04mg sodium per 1ml of the solution
What Caffeine Citrate 10mg/ml Solution for Injection looks like and contents of the pack
• Each 1ml ampoule of Caffeine Citrate 10mg/ml Solution for Injection contains 10mg of
caffeine citrate, equivalent to 5mg of caffeine
• Each 2ml ampoule of Caffeine Citrate 10mg/ml Solution for Injection contains 20mg of
caffeine citrate, equivalent to 10mg of caffeine
• Caffeine Citrate 10mg/ml Solution for Injection is available in ampoules of 1ml or 2ml, in
packs of 10 ampoules.
Marketing Authorisation Holder
Viridian Pharma Ltd, Yew Tree House, Hendrew Lane, Llandevaud, Newport, Gwent NP18 2AB
Manufacturer
Sterop, Avenue de Scheut 42-50, B – 1070 Brussels - BELGIUM
This leaflet was last revised in May 2014

160mm

160mm

418mm

PATIENT INFORMATION LEAFLET

Caffeine Citrate 10mg/ml Solution for Injection
Equivalent to Caffeine 5mg/ml
Please read all of this leaflet carefully before your baby is given this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask the hospital doctor who is looking after your
baby.
• If you notice any side effects, talk to your doctor. This includes any possible side effects
not listed in this leaflet. See section 4.
In this leaflet:
1. What Caffeine Citrate 10mg/ml Solution for Injection is and what it is used for
2. What you need to know before your baby is given Caffeine Citrate 10mg/ml Solution for
Injection
3. How Caffeine Citrate 10mg/ml Solution for Injection is given
4. Possible side effects
5. How Caffeine Citrate 10mg/ml Solution for Injection is stored
6. Contents of the pack and other information
1. What Caffeine Citrate 10mg/ml Solution for Injection is and what it is used for
• Caffeine belongs to a group of medicines known as methylxanthines
• It stimulates breathing, and is used to treat apnoea of prematurity (breathing difficulties as
a result of being born prematurely).
2. What you need to know before your baby is given Caffeine Citrate 10mg/ml Solution
for Injection
Your baby should not be given Caffeine Citrate 10mg/ml Solution for Injection if there is
known hypersensitivity (allergy) to any of the ingredients listed in Section 6 below.
Warnings and precautions
Talk to your doctor before Caffeine Citrate 10mg/ml Solution for Injection is given, if:
• Your baby has liver or kidney disease
• Your baby has had any unusual heart rhythms detected.
Other medicines and Caffeine Citrate 10mg/ml Solution for Injection
As with most medicines, Caffeine Citrate 10mg/ml Solution for Injection may interact with
other medicines given at the same time.
A premature baby may need many medicines, and any problems with caffeine are likely to
be minor, but tell the doctor about any other medication they may not know about,
particularly any other medicine (for example theophylline) given to your baby to help it
breathe.
If you, as the mother, drank a lot of coffee, or took any other high caffeine-containing
product just before your baby was born, some caffeine may still be present in your baby’s
circulation. Tell the doctor about this.
Medications containing phenobarbitone or phenytoin, taken by the mother herself to treat
epilepsy, may also have an effect on the way the baby reacts to caffeine therapy. If you have
been taking treatment for epilepsy during pregnancy, please tell your baby's doctor about it.
Caffeine Citrate 10mg/ml Solution for Injection contains sodium
Caffeine Citrate 10mg/ml Solution for Injection contains 3.04mg sodium per 1 ml of the
solution, which the doctor will need to consider if your baby is on a controlled sodium diet.

100mm Measurement Verification Bar

418mm

In very premature infants, clearance of caffeine does not depend on hepatic function. Hepatic caffeine metabolism
develops progressively in the weeks following birth and for the older infant, hepatic disease may reduce
maintenance caffeine dose requirements.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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